secwatch.observer — SEC 8-K summary
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Issuer:     GERON CORP (GERN)
CIK:        0000886744
Form:       8-K
Filed at:   2023-08-22T23:59:59+00:00
Accession:  0000950170-23-043949
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts Geron's NDA for imetelstat in lower-risk MDS; PDUFA date June 16, 2024
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- FDA accepted NDA for imetelstat for transfusion-dependent anemia in lower-risk MDS.
- Standard review assigned; PDUFA action date set for June 16, 2024.
- FDA currently plans to hold an advisory committee meeting as part of the review.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/886744/000095017023043949/0000950170-23-043949-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/886744/000095017023043949/gern-20230821.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-043949

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer